The one who clicks here
shall see much time pass before
        he is forgiven.
An Tir Chirurgeons' Guild

State of Maryland
Good Samaritan Laws

Maryland Annotated Code., Courts and Judicial Proceedings §5-309 (1982) (Gen. Stat)
Code of Maryland Annotated Regulations Title 30 subtitle 06 (AED)


Courts and Judicial Proceedings §5-309

(a) A person described in subsection (b) of this section is not civilly liable for any act or omission in giving any assistance or medical care, if:

(1) The act or omission is not one of gross negligence;

(2) The assistance or medical care is provided without fee or other compensation; and

(3) The assistance or medical care is provided:

(i) At the scene of an emergency;
(ii) In transit to a medical facility; or
(iii) Through communications with personnel providing emergency assistance.

(b) Subsection (a) of this section applies to the following:

(1) An individual who is licensed by this State to provide medical care;

(2) A member of any State, county, municipal, or volunteer fire department, ambulance and rescue squad or law enforcement agency or of the National Ski Patrol System, or a corporate fire department responding to a call outside of its corporate premises, if the member:

(i) Has completed an American Red Cross course in advanced first aid and has a current card showing that status;
(ii) Has completed an equivalent of an American Red Cross course in advanced first aid, as determined by the Secretary of Health and Mental Hygiene; or
(iii) Is certified by this State as an emergency medical technician or cardiac rescue technician;

(3) A volunteer fire department, ambulance and rescue squad whose members have immunity;

(4) A corporation when its fire department personnel are immune under paragraph (2) of this subsection.

(c) An individual who is not covered otherwise by this section is not civilly liable for any act or omission in providing assistance or medical aid to a victim at the scene of an emergency, if:

(1) The assistance or aid is provided in a reasonably prudent manner;w
(2) The assistance or aid is provided without fee or other compensation; and
(3) The individual relinquishes care of the victim when someone who is licensed or certified by this State to provide medical care or services becomes available to take responsibility.

Title 30 MARYLAND INSTITUTE FOR EMERGENCY MEDICAL SERVICES SYSTEMS (MIEMSS)

Subtitle 06 AUTOMATED EXTERNAL DEFIBRILLATOR PROGRAM

Chapter 01 Definitions

Authority: Education Article, §13-517, Annotated Code of Maryland

.01 Definitions.

A. In this subtitle, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Approved training program" means an organization, business, association, or agency that has been approved by MIEMSS to provide AED training for individuals who will operate the device at authorized AED facilities.

(2) Authorized Facility.

(a) "Authorized facility" means an organization, business, association, or agency that meets the requirements of the EMS Board for providing automated external defibrillation.

(b) "Authorized facility" may include multiple sites.

(3) "Automated external defibrillator (AED)" means a medical heart monitor and defibrillator device that:

(a) Is cleared for market by the federal Food and Drug Administration;

(b) Recognizes the presence or absence of ventricular fibrillation or rapid ventricular tachycardia;

(c) Determines, without intervention by the operator, whether defibrillation should be performed;

(d) On determining that defibrillation should be performed, automatically charges; and

(e) Either:

(i) Requires operator intervention to deliver the electrical impulse, or

(ii) Automatically continues with delivery of electrical impulse.

(4) "Cardiopulmonary resuscitation (CPR) training" means training in adult cardiopulmonary resuscitation which, at a minimum, includes:

(a) Patient assessment;

(b) Mouth-to-mouth breathing;

(c) Mouth-to-mask breathing;

(d) Chest compressions; and

(e) Relief of foreign body airway obstruction on an unconscious and conscious patient.

(5) "Event (code) summary" means the electronic report of an AED operation produced by an AED.

(6) "Facility" means an agency, association, corporation, firm, partnership, or other entity.

(7) "Medical direction" means the medical oversight, including quality assurance, planning, and education, provided by a sponsoring physician to an authorized facility.

(8) "Nationally recognized AED instructor training program" means an organization determined by MIEMSS to:

(a) Be nationally recognized as having the resources, experience, and expertise to:

(i) Set minimum standards for the instruction in operation of an AED, and

(ii) Provide adequate quality assurance of its instruction and instructors;

(b) Have a valid, reliable instrument for the evaluation of the training of persons in instruction in the use of an AED; and

(c) Have affiliates, members, or persons whom it officially recognizes as meeting its standards in at least 26 states, and whose members meet specified qualifications.

(9) "Nationally recognized AED training program" means an organization determined by MIEMSS to:

(a) Be nationally recognized as having the resources, experience, and expertise to:

(i) Set minimum standards for training in the operation of an AED, and

(ii) Provide adequate quality assurance of its instruction and instructors;

(b) Have a valid, reliable instrument for the evaluation of the training of persons in the operation of an AED; and

(c) Have affiliates, members, or persons whom it officially recognizes as meeting its standards in at least 26 states and whose members meet specified qualifications.

(10) "Operate" means to use or attempt to use an AED to defibrillate an individual whether or not any electrical impulse is delivered.

(11) "Public safety answering point (PSAP)" has the meaning stated in Public Safety Article, §1-301(q), Annotated Code of Maryland.

(12) "Response" means the removal of the AED from its storage location for the purposes of rendering care whether or not the care is actually rendered.

(13) "Site" means a building, plant, unit, branch, vehicle, or other ancillary location that is part of or affiliated with a facility.

(14) "Sponsoring physician" means a physician who:

(a) Is licensed to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland;

(b) Provides medical direction to an authorized facility; and

(c) Meets the qualifications established by the EMS Board.

Chapter 02 Approval of Authorized Facilities and Compliance

.01 Criteria for Authorization of Facilities.

To be eligible for authorization, or renewal of authorization, to operate an AED under this subtitle, an authorized facility shall:

A. Have a sponsoring physician:

(1) Who meets all requirements of COMAR 30.06.03.02B; and

(2) Whose duties and responsibilities meet the requirements of COMAR 30.06.03.02C;

B. Designate an AED coordinator who shall:

(1) Either:

(a) Be certified or licensed in Maryland as an EMS provider other than a first responder who received their initial certification before July 2003 or has not successfully completed an update training after July 2003, or emergency medical dispatcher; or

(b) Have successfully completed either:

(i) An AED training course, incorporating CPR training, provided by an approved AED training program, or

(ii) An AED training course provided by an approved AED training program and, before enrollment in the AED training course, CPR training;

(2) Successfully complete refresher training for CPR and AED required under COMAR 30.06.05; and

(3) Be responsible for implementing and administering the AED program at the authorized facility in compliance with this subtitle;

C. Provide an orientation to the operation, maintenance, and location of the authorized facility's AEDs to all individuals who will be authorized to operate an AED for the authorized facility;

D. Implement a quality assurance and maintenance program at each site at which the AED is operated which meets the requirements of COMAR 30.06.04;

E. Adopt written operational policies and procedures regarding the operation and maintenance of the AED at each site at which an AED is operated which shall be subject to and available for inspection by MIEMSS;

F. Place all AEDs in locations which comply with the requirements of the AED protocol in COMAR 30.06.03.03;

G. Have a telephone or other communication service available at all times at each site at which an AED is operated, for the notification of the public safety answering point;

H. Submit data or other information concerning the AED program which may be periodically requested by MIEMSS; and

I. Require that all individuals operating an AED for the facility:

(1) Follow the protocol in COMAR 30.06.03.03 whenever operating an AED for the facility; and

(2) Are 18 years old or older, except that an individual who is 16 or 17 years old may be authorized to operate an AED with written permission from a parent or legal guardian; and

J. Provide scenario-based practice drills for all individuals operating an AED for the facility every 12 months at a minimum unless providing AED refresher training consistent with the requirements of an approved AED training program annually.

.02 Application and Authorization Process.

A. A facility that operates AEDs as of October 1, 1999, may continue until MIEMSS has completed the authorization process with respect to that facility, if the facility applies to be an authorized facility within 90 days of the adoption of this regulation.

B. A facility seeking authorization or renewal of authorization shall:

(1) Submit an application and all required documentation to MIEMSS on the form required by MIEMSS; and

(2) Pay the required fee of $25 for:

(a) Initial authorization, or

(b) Renewal.

C. MIEMSS may make the inspection and require the verification necessary to ensure that an applicant meets the requirements of this chapter, including an inspection of the facility, any sites, equipment, and records.

D. MIEMSS shall issue a certificate of authorization or renewal to a facility that meets the requirements of Regulation .01 of this chapter.

E. The certificate of authorization or renewal is valid for a period of 3 years.

.03 Denial of Authorization.

A. MIEMSS may deny an application if it finds that the applicant fails to meet the requirements of this chapter.

B. Notice of Denial.

(1) MIEMSS shall issue a written notice of denial to an applicant that includes the reasons for denial.

(2) The notice shall conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland.

C. An applicant denied approval may file an appeal with the EMS Board under Regulation .05 of this chapter.

D. If an applicant does not file a timely appeal under Regulation .05 of this chapter, the decision is final.

E. If an application is denied, the applicant may reapply under this chapter.

.04 Compliance.

A. MIEMSS may initiate a compliance review of an authorized facility upon information that the authorized facility has failed to comply with this subtitle.

B. MIEMSS shall give written notice of the compliance review to the authorized facility.

C. In the course of its compliance review, MIEMSS may:

(1) Inspect all:

(a) Sites where the authorized facility maintains an AED,

(b) Records relating to the AED and supplemental equipment,

(c) Records relating to the CPR and AED training of all personnel authorized to operate an AED at the facility,

(d) Records relating to the operation of an AED, and

(e) Equipment related to the AED; and

(2) Interview employees of the authorized facility regarding the AED program.

D. If MIEMSS finds that an authorized facility has failed to comply with this subtitle, MIEMSS may:

(1) Suspend the facility's authorization;

(2) Revoke the facility's authorization;

(3) Refuse to renew a facility's authorization; or

(4) Take other action as appropriate.

E. Within 30 days after the conclusion of the compliance review, MIEMSS shall provide its findings, decision and any proposed action in writing to the:

(1) Authorized facility; and

(2) EMS Board.

F. The report shall:

(1) Conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland; and

(2) Contain the reasons for the decision and the proposed action.

G. Upon receipt of the report and proposed action, an authorized facility may file an appeal with the EMS Board under Regulation .05 of this chapter.

H. If an applicant does not file a timely appeal under Regulation .05 of this chapter, MIEMSS' proposed decision is final.

.05 Procedure for Appeals.

A. An applicant or authorized facility may appeal a disputed decision by filing a notice of appeal to the EMS Board with the Executive Director of MIEMSS not later than 20 days after receipt of the decision.

B. The appeal shall state with specificity the reasons why the disputed decision should be modified.

C. An applicant or authorized facility that files an appeal shall be granted a hearing before the:

(1) EMS Board; or

(2) Office of Administrative Hearings, if the Board so elects and notifies the applicant or authorized facility.

D. An appeal hearing shall be governed by COMAR 28.02.01.

E. If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 also apply.

F. An applicant or authorized facility which has participated in a hearing under this regulation may seek judicial review of the EMS Board's final action under State Government Article, §10-222, Annotated Code of Maryland. The EMS Board shall be party to the proceeding.

.06 Confidentiality of Records.

MIEMSS shall maintain the confidentiality of records referred to in this subtitle in accordance with:

A. Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland;

B. Health Occupations Article, Title 10, Subtitle 5, Annotated Code of Maryland; and

C. State Government Article, Title 10, Subtitle 6, Part III, Annotated Code of Maryland.

Chapter 03 Medical Direction and Protocol

.01 Scope.

This chapter governs the requirements for medical direction of authorized facilities.

.02 Authorized Facility Sponsoring Physician.

A. Each authorized facility shall have a sponsoring physician.

B. A sponsoring physician shall meet the following qualifications:

(1) Be licensed to practice medicine in Maryland;

(2) Be knowledgeable in the operation of the AEDs available at the facility; and

(3) Possess current knowledge of the:

(a) Maryland EMS System,

(b) AED protocol in Regulation .03 of this chapter, and

(c) AED quality assurance process in COMAR 30.06.04.

C. The sponsoring physician shall perform the following duties:

(1) Be responsible for providing medical direction for the operation of AEDs at the authorized facility;

(2) Require that all personnel operating an AED for the authorized facility meet the training requirements of COMAR 30.06.05;

(3) Oversee the quality assurance program as required in COMAR 30.06.04;

(4) Liaise with the local EMS jurisdictional operational program medical director and the State EMS Medical Director; and

(5) Require that all personnel in the AED program are following the protocol required in Regulation .03 of this chapter when operating the AED.

D. The authorized facility shall notify the office of the State EMS Medical Director immediately of any change of its sponsoring physician.

.03 Protocol.

All personnel in the AED program at an authorized facility shall have access to and follow the following protocol when operating an AED:

Indications

‚?? Sudden cardiac arrest ‚?? Patient without signs of circulation and not breathing.

‚?? Infant 12 months ‚?? Child 8 years ‚?? If available, pediatric AED only. Child 8 years old or older ‚?? Adult AED

Contraindications

‚?? Infant less than 12 months old (estimate based upon information available to individual operating AED).

‚?? Patient is breathing, responsive, speaking, or making intentional movements.

Potential Adverse Effects/Complications

‚?? Burns to skin.

‚?? Deactivation of patient's implanted pacemaker.

‚?? Injury to patient, self, and/or bystanders.

Precautions/Critical Concepts

‚?? Wet conditions ‚?? Make sure the patient and environment are dry (this includes removing nitroglycerin paste from the chest with a dry cloth).

‚?? Metal surfaces ‚?? Make sure patient is not touching any metal surfaces.

‚?? Combustible materials or hazardous (explosive) environment ‚?? Remove patient, if possible, from area which presents hazard.

‚?? Do not touch patient while AED is assessing, charging, or shocking patient.

‚?? Ensure patient is "clear" (no one is touching patient) when shock button is pushed.

‚?? If patient has internal pacemaker/defibrillator, position pad 1 hand's width (approximately 5 inches) from the pacemaker/defibrillator site. If patient has a nitroglycerin patch, position patches away from the patch.

‚?? Never defibrillate while moving patient.

‚?? Location of AED(s) should provide optimal accessibility to the maximum number of individuals and authorized operator(s) at the facility. Upon placement of AED consider the following:

1. No obstacles in the way of AED.

2. Avoid locked doors preventing quick access to AED.

3. Areas of facility with large numbers of high-risk individuals.

4. Length of time and distance to AED.

5. The AED is placed in a location clearly visible to the authorized operators.

Chapter 04 Quality Assurance and Maintenance

.01 Scope.

This chapter governs the requirements for quality assurance and maintenance for authorized facilities.

.02 Quality Assurance and Maintenance.

A. Each authorized facility shall have a quality assurance and maintenance program consistent with the requirements of this regulation.

B. An authorized facility shall implement a quality assurance program which, at a minimum, provides for:

(1) Review by the authorized facility's sponsoring physician of each incident in which an AED was operated or there was a response with an AED to determine the appropriateness of the operation of the AED or the AED response;

(2) For each incident in which the sponsoring physician determines that the use of the AED was inappropriate:

(a) A conference among the individual operating or responding with the AED, the AED coordinator, and the sponsoring physician, and

(b) Submission of a report to the State EMS Medical Director summarizing the conclusions of the review and conference;

(3) Reporting each incident as required by §B(5) of this regulation;

(4) Compliance with all requirements of the federal Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992; and

(5) Remedial action as necessary to resolve any issues of compliance with this subtitle.

C. An authorized facility shall adopt written procedures for the implementation and administration of the quality assurance and maintenance program which has been approved by the authorized facility's sponsoring physician.

D. An authorized facility shall maintain:

(1) The certificate issued by MIEMSS in a place where it is readily available;

(2) Each AED and all related equipment and supplies in accordance with the standards established by the device manufacturer and the federal Food and Drug Administration;

(3) Supplemental equipment with the AED at all times as follows:

(a) 2 sets of defibrillator chest pads,

(b) 2 pocket face masks,

(c) Disposable gloves,

(d) 2 safety razors, for shaving patient's chest, if necessary for proper defibrillator pad contact,

(e) 1 absorbent towel,

(f) 5 ‚?? 4x4 inch gauze pads,

(g) 1 extra battery set, if the AED uses replaceable batteries other than long life lithium batteries,

(h) Cables, if the AED has removable cables, and

(i) Maryland Facility AED Report Forms for Cardiac Arrest;

(4) All AED storage areas, equipment, and supplies clean and sanitary;

(5) Each AED in a closed, intact case with no visible signs of damage that would interfere with its use;

(6) Written records of :

(a) The dates and frequency of manufacturer recommended maintenance as well as the name of the company performing maintenance,

(b) All repairs performed on the AED, as well as the date and service company performing the repairs,

(c) Dates and frequency of routine safety inspection of the AED, documentation of properly functioning AED, and the individual inspecting the AED,

(d) Completion of training requirements and current proficiency in AED operation for personnel authorized to operate AEDs for the authorized facilities, including dates of initial CPR and AED training, subsequent required refresher training, and practice drills,

(e) The name, address, and telephone number of the sponsoring physician and verification that the physician meets the required qualifications,

(f) Completed MIEMSS Maryland Facility Cardiac Arrest Form for each incident in which the AED was operated or there was an AED response, and

(g) Completed FDA AED malfunction form for each incident in which an AED malfunctioned.

E. An authorized facility shall conduct and maintain written logs of daily safety inspections of all supplemental and AED equipment, including assurance of adequate battery charge, per the manufacturer's guidelines.

F. An authorized facility shall submit:

(1) A report for each incident in which an AED is operated or there was an AED response, on the Maryland Facility AED Report Form for Cardiac Arrests, including any event (code) summary, recording, or tape created by the AED:

(a) To the office of the State EMS Medical Director, and

(b) If the PSAP is accessed, to the local jurisdictional EMS operational program; and

(2) If the AED fails when operated, in addition to submitting the required report to the federal Food and Drug Administration, a copy of the report to the State EMS Medical Director.

G. An authorized facility shall ensure the confidentiality of any medical records maintained by the authorized facility in accordance with Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland.

Chapter 05 Training Requirements

.01 Training Requirements.

Each individual who operates an AED for an authorized facility shall:

A. Either:

(1) Have successfully completed:

(a) An AED training course, incorporating CPR training, provided by an approved AED training program;

(b) An AED training course provided by an approved AED training program, and CPR training before enrollment in the AED training course; or

(c) An AED and CPR training program in another state which authorizes the individual to provide AED in another state; or

(2) Be certified or licensed in Maryland as an emergency medical services provider other than a first responder who received their initial certification before July 2003 or has not successfully completed an update training after July 2003, or emergency medical dispatcher;

B. Either:

(1) Receive refresher training consistent with the requirements of an approved AED training program; or

(2) Maintain current certification or licensure in Maryland as an emergency medical services provider other than an emergency medical dispatcher; and

C. Receive refresher CPR training every 2 years unless included in the refresher AED training course or emergency medical services provider continuing education; and

D. Participate in scenario-based practice drills every 12 months at a minimum unless receiving AED refresher training consistent with the requirements of an approved AED training program annually.

.02 Approval of an AED Training Program.

A. To be eligible for approval or renewal of approval, a training program shall:

(1) Submit an application on a form approved by MIEMSS, along with a complete description of the course curriculum;

(2) Be:

(a) A nationally recognized AED training program, or equivalent as determined by MIEMSS;

(b) A Maryland Higher Education Commission accredited post-secondary institution; or

(c) An emergency services training academy operated by any city, county, or municipal government;

(3) Use instructors who:

(a) Have either

(i) Successfully completed a nationally recognized AED instructor training program, or

(ii) Been approved by MIEMSS as emergency medical services instructors; and

(b) Provide proof of current proficiency in AED instruction;

(4) Use a nationally recognized AED training curriculum, including any curricula developed by the American Heart Association, the American Red Cross, the National Safety Council, or the United States Department of Transportation, which, at a minimum, includes the following training objectives:

(a) Briefly define, explain, describe, or identify the importance of AED and the principles of early defibrillation;

(b) Explain the components of an appropriate response to sudden cardiac arrest and how early defibrillation fits into the concept;

(c) Briefly define, explain, describe, or identify the rationale that supports the concept of early defibrillation;

(d) Briefly describe or identify the types of AEDs that are available;

(e) Describe or identify the indications for the AED;

(f) Describe or identify contraindications to the AED;

(g) Briefly explain or identify how the automated analysis of cardiac rhythm occurs;

(h) Briefly explain or identify how these devices respond to ventricular fibrillation and rapid ventricular tachycardia;

(i) Explain or identify what modifications to CPR procedures are necessary when the AED is being operated;

(j) Describe or identify the appropriate age guidelines;

(k) Explain or identify the procedural steps for performing AED;

(l) Given a minimum of three patient care scenarios in which the AED is indicated, properly demonstrate use of the device and explain why the device is appropriate or not appropriate; and

(m) Define, explain, describe, or identify site-specific hazardous environment safety precautions and considerations for AED use;

(5) Provide training in the Maryland protocol for public access defibrillation;

(6) Require and provide refresher AED training which addresses all of the cognitive and psychomotor skills objectives as required in the initial training consisting of a minimum of:

(a) 4 hours every 2 years for an AED training course incorporating CPR; and

(b) 3 hours every 2 years for an AED training course which does not incorporate CPR;

(7) Have a medical director; and

(8) Maintain a quality control program including instructor evaluation and review.

B. MIEMSS shall approve each AED training program which meets the requirements of §A of this regulation.

C. Each approval or renewal of approval shall be:

(1) Valid for 1 year; and

(2) Renewed for an additional year at the end of that period without making further application, if the training program continues to meet the requirements for approval in compliance with this subtitle.

.03 Denial.

A. MIEMSS may deny an application for approval as a training program if it finds that the applicant does not meet the requirements of Regulation .02 of this chapter.

B. Notice of Denial.

(1) MIEMSS shall issue a written notice of denial to an applicant that includes the reasons for denial.

(2) The notice shall conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland.

C. An applicant denied approval may file an appeal with the EMS Board under Regulation .04 of this chapter.

D. If an applicant does not file a timely appeal under Regulation .04 of this chapter, MIEMSS' decision is final.

E. If an application is denied, the applicant may reapply under this chapter.

.04 Procedures for Appeals.

A. An applicant may appeal a disputed final decision by filing a notice of appeal to the EMS Board with the Executive Director of MIEMSS not later than 20 days after receipt of MIEMSS' decision.

B. The appeal shall state with specificity the reasons why the disputed decision should be modified.

C. An applicant that files an appeal shall be granted a hearing before the:

(1) EMS Board; or

(2) Office of Administrative Hearings, if the Board so elects and notifies the applicant or facility.

D. An appeal hearing shall be governed by COMAR 28.02.01.

E. If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 also apply.

F. An applicant which has participated in a hearing under this regulation may seek judicial review of the EMS Board's final action under State Government Article, §10-222, Annotated Code of Maryland. The EMS Board shall be party to the proceeding.

The information contained in this Site is for general guidance on matters of interest only. The application and impact of laws can vary widely based on the specific facts involved. Given the changing nature of laws, rules and regulations, and the inherent hazards of electronic communication, there may be delays, omissions or inaccuracies in information contained in this Site. Accordingly, The information on this Site is provided with the understanding that the authors and publishers are not herein engaged in rendering legal advice or services. As such, it should not be used as a substitute for consultation with professional legal advisers.

While we have made every attempt to ensure that the information contained in this Site has been obtained from reliable sources, the authors and publishers are not responsible for any errors or omissions, or for the results obtained from the use of this information. All information in this Site is provided "as is", with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind. In no event will the authors and publishers be liable to you or anyone else for any decision made or action taken in reliance on the information in this Site or for any consequential, special or similar damages, even if advised of the possibility of such damages.



Viewable with ANY brower!    Valid HTML 4.01!    Valid CSS!